Director, Regulatory Affairs

The Director, Regulatory Affairs is responsible for the management and leadership of regulatory development activities for assigned products. In this role, the Director is responsible for representing Regulatory Affairs at core team and sub-team meetings and other scientific review teams. The Director is responsible for development of relevant sections of global core dossiers for assigned products.

Key accountabilities include providing scientific and technical regulatory guidance and strategy to key internal stakeholders to advance the development of novel compounds and life cycle development of assigned products as well as assuring compliance with global regulatory standards and commitments.

Essential Responsibilities:

• Liaison responsibility on behalf of Regulatory Affairs for ensuring effective and professional technical relationships with internal drug development teams, external scientific experts in the drug development arena and health authorities.
• Provides global regulatory strategic insight and regulatory procedural expertise in line with applicable regulatory guidelines.
• Ensures accurate and timely compilation and submission of regulatory documentation.

• Represents Regulatory Affairs at core team meetings including other assigned teams i.e. sub-teams.
• Applies influence and negotiation skills to drive development results and resolve issues.
• Ensures effective execution of optimal strategies for development programs in responsible areas.
• Ensures global regulatory compliance standards and commitments are met.
• Responsible for developing and maintaining regulatory and technical sections of global CTD filings to ensure compliance of global filings in line with company scientific data.
• Ensures global strategic consistency across regional regulatory submissions by contributing to and reviewing regional-specific technical strategic regulatory documentation.

• Ensures applicable regulatory requirements are considered and appropriately incorporated into all programs, ensuring compliance with appropriate regulations and guidelines.

• Sets quality and accuracy standards for global regulatory technical documentation.
• Collaborates with key internal partners and other key stakeholders to support a globally effective organization.
• Supports new Business Development initiatives including due diligence and regulatory technical assessments as needed.

Requirements:

• Bachelor's Degree in Life Science or other related discipline. Advanced degree preferred. Equivalent combination of education and applicable job experience may be considered.
• Minimum of 10 years' regulatory experience in the pharmaceutical and biotechnology industry or Government Health Agency, with at least 5 years' experience in a regulatory leadership role.
• Demonstrated track record of successful approvals from a major regulatory agency is required. Prior regulatory agency liaison experience is essential.
• Strong expertise and knowledge of the drug development process is required. Experience in drug safety, pharmacovigilance and/or risk management preferred.

Additional Responsibilities:

• Strong ability to apply scientific principles to assess regulatory issues, request and collect relevant information, analyze data, establish facts and draw valid conclusions.
• Excellent interpersonal, communication, analytical and organizational skills.
• Strong influencing and negotiation skills.
• Capable of managing multiple projects and complex timelines in a team environment.
• Ability to function effectively in a global scientific and cultural arena.
• Demonstrate leadership capacity in a highly matrix working environment by interacting effectively with internal departments and external organizations
• Excellent team management skills, ability to lead, train and mentor team members at all levels.
• Works independently under general supervision. Exercises judgment within generally defined practices and policies.
• Ensures effective liaison with regulatory affairs counterparts to ensure aligned representation and decision making at assigned teams.
• Ability to travel 10-20% domestic and internationally.

Retrophin, Inc. is an EEO/AA/Veteran/Disability Employer